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In favor: Allos, Beck, Campbell, Finger, Gilsdorf, Hull, Lieu, Marcuse, Morita, Treanor, Womeodu, Abramson
The vote passed.
Recommendations for Hepatitis A Vaccination of Children
Presenter: Dr. Beth Bell, N.C.I.D.
Overview: Review of hepatitis A epidemiology; progress of past and current recommendations’ implementation; proposed language on: 1) routine vaccination of 1 year old children nationwide; 2) maintaining vaccination of 2 to 18 year old children in areas with existing programs; and 3) consideration of vaccination of 2 to 18 year old children in areas without existing programs.
A.C.I.P. recommendations for hepatitis A vaccination of children have been implemented incrementally, beginning in 1996 with vaccination of children living in so-called “high rate” communities. In 1999, the A.C.I.P. took another incremental step by recommending routine vaccination of children living in states and communities with hepatitis A incidence rates that were consistently higher than the national average during a defined baseline period in the pre-vaccine era. The A.C.I.P. indicated that the final step in the incremental strategy was routine vaccination of all children nationwide, and that implementation of this policy would be facilitated by the availability of hepatitis A vaccines for use in children aged less than 2 years. Routine vaccination of children nationwide would allow consideration of elimination of indigenous hepatitis A virus (H.A.V.) transmission.
The 17 states in which, according to the 1999 A.C.I.P. recommendations, routine hepatitis A vaccination of children was recommended or should be considered include approximately 33 percent of the U.S. population, but approximately 66 percent of the reported hepatitis A cases during the pre-vaccine era baseline period.
The 1999 recommendations included permissive language with respect to implementation strategies. They suggested determining the age groups to be vaccinated based on community disease patterns and proposed a number of possible vaccination strategies (for example, one or more single-age cohorts, in selected settings such as day care, or children in a wide age range when they presented for medical care). As a result, approaches and implementation have varied considerably among the states in the five years since the recommendations were made.
Current vaccination coverage.
Remarkable changes in hepatitis A epidemiology have been observed since implementation of the 1999 recommendations. Overall incidence has declined, with sharper declines in the areas in which vaccination was recommended. In 2004, the incidence rate was 1.9 per 100,000 ─ the lowest rate in the approximately 40 years that these data have been collected. Declines occurred in all age groups, but were greater among children. In the pre-vaccine era, rates among children were consistently higher than those of adults, but since 2001, rates among children have been lower than among adults. Differences in hepatitis A incidence among racial/ethnic groups also have narrowed or been eliminated. In the pre-vaccine era, hepatitis A incidence among American Indians and Alaska Natives was approximately10 times higher than among whites, but currently is among the lowest of any racial/ethnic group. Rate differences between Hispanics and non-Hispanics have also narrowed, although rates remain higher among Hispanics.
In examining recent trends in hepatitis A incidence by age group, it can be seen that the rates among children aged 2 to 9 years living in areas where vaccination is recommended steadily declined to 2003 and then plateaued in 2004. Among children living in areas where vaccination is not recommended, there was a slight increase in incidence in 2004 compared to 2003, and this group had the highest age- and region-specific rate in 2004. A similar pattern was observed for those aged 10 to 18 years, with plateauing of rates in both vaccinating and non-vaccinating regions. Incidence rates among adults continued to decline in both regions and most of the overall decline in incidence between 2003 and 2004 was attributable to declines among adults.
The distribution of cases by age group and region during the pre-vaccine era and in 2004 was compared. The overall proportion of cases among children fell from approximately 36 percent to 27 percent. Whereas in the pre-vaccine era approximately two thirds of all cases were reported from states in which vaccination was then recommended, in 2004 cases from these vaccinating states accounted for about one third of cases and approximately 66 percent of cases in 2004 occurred in areas not using vaccine.
In vaccinating states, the incidence among Hispanic children has dramatically declined, to 2.9 per 100,000, but this rate remains somewhat higher than among non-Hispanic (0.5 per 100,000) children. In the non-vaccinating states, the difference in the incidence rate between Hispanic (7.1 per 100,000) and non-Hispanic (1.0 per 100,000) children remains large. The 2004 rate among Hispanic children in non-vaccinating states was the highest age-specific rate in either vaccinating or non-vaccinating states.
In summary, the overall hepatitis A incidence rate has continued to fall in recent years, primarily because of continuing declines among adults; rates among children appear to have plateaued. Despite this progress, about 5,000 to 7,000 cases are reported each year, and an estimated 20,000 to 30,000 symptomatic cases occur. Rates are similar across regions, and are highest among Hispanic children in non-vaccinating states. Most cases are reported from states without routine vaccination recommendations.
Although difficult to predict with any certainty, if the current A.C.I.P. recommendations were to be maintained unchanged, theoretical models of incidence dynamics when a new vaccine is introduced predict an initial nadir followed by a rebound to a new steady state, which will be lower than before vaccine introduction but higher than the nadir. A model of expected incidence predicts 5000 to 11,000 cases per year over the next ten years without immunization in the non-vaccinating states.
Nationwide vaccination of children with hepatitis A vaccine will move this childhood vaccination into the mainstream, improving its sustainability and increasing the probability of achieving high coverage. It is consistent with the incremental strategy. The availability of two vaccines for use from 12 months of age will allow the incorporation of hepatitis A vaccine into the routine childhood vaccination schedule. Nationwide routine vaccination of children is likely to result in lower rates over time, to further narrow demographic disparities, and allow eventual consideration of elimination of indigenous transmission. The economic analyses of this strategy are favorable.
Working Group Discussions/Economic Analyses
Presenter: Dr. Tracy Lieu, Working Group Chair
In early September, a poll of A.C.I.P. members revealed general support for universal hepatitis A vaccination, although a few members were undecided. The A.C.I.P. hepatitis vaccines Working Group also supported universal vaccination. Several key questions arose from the working group deliberations as well in discussions with other A.C.I.P. members:
Why is universal vaccination needed now? The 1999 A.C.I.P. recommendations for “high-incidence” states were an interim step; A.C.I.P.’s intent has always been to eventually implement nationwide hepatitis A vaccination. Hepatitis A vaccines are now available for use in one-year-olds, improving the feasibility of this strategy, as initially envisaged by the A.C.I.P. Finally, the current policy of vaccination in “high-incidence” states is not sustainable.
Why is the status quo not sustainable? The policy of selective vaccination is not sustainable because states that used to be “high-incidence” now have lower incidence than the “low-incidence” states where vaccination is not recommended. Hence the rationale for continued vaccination in these areas doesn’t make sense to people, and anecdotal evidence suggests that states may lose support for continued vaccination. Even if selective vaccination were sustainable, its impact probably would not be sustained, as shown by plateaued disease rates among children and the persistence of disparities. Without universal vaccination, models predict that hepatitis A incidence probably would rise again.
Cost-benefit of universal vaccination. Predictions of the C.D.C.-R.T.I. economic model were summarized.
Health Benefit (annual, with vaccination at age 1 year):
Costs (annual, with vaccination at age 1 year):
For these reasons, the Working Group reached consensus to support this recommendation. However, they also agreed that the added vaccine financing of this and other new vaccine recommendations needs to be addressed in the larger context of A.C.I.P.
Proposed Recommendation Wording
Dr. Lieu moved to support the hepatitis A recommendation with the friendly amendments to clarify it. Dr. Campbell seconded the motion.
In favor: Allos, Beck, Campbell, Finger, Gilsdorf, Hull, Lieu, Marcuse, Morita, Womeodu, Abramson
|Jane D. Siegel, md; Emily Rhinehart, rn mph cic; Marguerite Jackson, PhD; Linda Chiarello, rn ms; the Healthcare Infection Control Practices Advisory Committee||Ranch hand advisory committee|
|Veterinary medicine advisory committee||Medical Devices Advisory Committee|
|External Advisory Committee on Cities and Communities||Wildlife Diversity Policy Advisory Committee|
|National Vaccine Advisory Committee (nvac)||Peer reviewed by the Arizona Department of Commerce Economic Research Advisory Committee|
|Food and drug administration national institutes of health advisory Committee on: transmissible spongiform||Advisory Committee, Cuyahoga Valley School-to-Career Consortium, Broadview Heights, Ohio 1996-2002|